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New Drug Application
Here's a nice read.
http://www.npr.org/sections/health-shots/2015/03/11/392355433/results-of-many-clinical-trials-not-being-reported
"A study from Duke University finds that five years after the reporting law took effect, only 13 percent of scientists running clinical trials had reported their results."
"About half of the missing reports from industry-sponsored research were temporarily exempt. Companies are allowed to sit on their data at times to preserve a competitive advantage if they're trying to develop a new drug."
Do the math
Bought by $200,000 at .07...
It's called Fear,Uncertainty & Doubt or FUD for short.
The hope is to frighten folks.
All stocks have risk and I continue to like the risk/reward profile of ELTP.
Oh ok, De Nile being a river in Egypt...
Got HAL studies? ELTP sure does!
Glad I bought a stock and not a chart.
Whats with the five decimal place prices?
0.41287 ? Really?
More like a cub raid.
Its like getting twenty .02's!
Did they have to give the $5 million back? No.
No this is not even remotely toxic financing to Elite. This is a real company making real revenue with real products. They will get off the OTC when the stock price gets well over a buck which is likely to happen by middle of 2016. Might happen with NDA filing acceptance by FDA in early January. Once it's well over a buck they may reverse split and uplist to Nasdaq.
Or they might just get bought.
Company is making great strides .
"Unless otherwise clinically indicated, emergency department physicians and providers should not prescribe long-acting or controlled release opioids. If indicated, prescribers should provide tamper-resistant, or abuse
deterrent, forms of opioids.i, ii"
Did a quick Google...
On Monday, Shares of Arena Pharmaceuticals, Inc. (NASDAQ:ARNA), gained 11.16% to $2.39.
Eisai Inc. and Arena Pharmaceuticals, declared that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for an extended release formulation of lorcaserin. If approved, the extended release formulation will offer patients a chronic weight administration treatment in a once-daily dosing option.
http://www.wsnewspublishers.com/notable-stocks-in-the-spotlight-arena-pharmaceuticals-inc-nasdaqarna-chicos-fas-inc-nysechs-paychex-inc-nasdaqpayx/1542206/
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This stock spiked 40% on day of announcement.
Lightlake Therapeutics Inc. Announces FDA Accepts for Review Adapt Pharma Limited's NARCAN(R) (Naloxone Hydrochloride) Nasal Spray NDA and Grants Priority Review Status - See more at:
http://globenewswire.com/news-release/2015/09/25/771050/10150583/en/Lightlake-Therapeutics-Inc-Announces-FDA-Accepts-for-Review-Adapt-Pharma-Limited-s-NARCAN-R-Naloxone-Hydrochloride-Nasal-Spray-NDA-and-Grants-Priority-Review-Status.html#sthash.cF8QPTos.dpuf
Maz:
As far as I know...no real way we can know what LPC has sold to date. We know from the last 10-Q that they had bought 60.3 million shares to date at market at an average of about .27/share.
"Through November 9, 2015, we have sold to Lincoln Park an aggregate of 60.3 million shares under the Purchase Agreement for aggregate gross proceeds of approximately $16.0 million. In addition, we have issued an additional 0.8 million Commitment Shares."
ELTP can "put" shares valued at up to $40,000,000 to LPC. (With certain caveats).
Now that being said they can be off our backs whenever Elite wants them to be. There is NO obligation on Elite's part to put more shares to LPC. Between the increased cash flow from generics and the $15,000,000 from Epic for milestones Elite does not need the LPC funding quite as much as they did before.
Still, Elite is likely to continue to tap LPC to some degree so that they can accelerate the development of 201, 202 etc.
Assuming another $24,000,000 to go at an average price of .60 between now and next year (wild ass guess) we are probably looking at another 40 million shares to be added to outstanding at the very most.
Of course we could get bought out next month and who cares?
The Legal Drug That Kills More People Than Heroin
http://www.iflscience.com/health-and-medicine/graph-showing-rise-americas-recent-drug-problem
LOL, check out the 65.7 day Fibonacci algorithm spasm. Geez....
resistance is futile.
Nonsense. My wife and I both earn 6 figures. I have been invested in this company for quite some time. No regrets at all.
It was .44 just 11 days ago
The official decision on priority review comes within 60 days of acceptance of the NDA application. But given that many abuse-deterrent formulations to date were already granted Fast-Track there is no reason in my mind to doubt that Nasrat has already discussed and gotten assurances from the FDA that this is worthy of priority review.
Doesn't make me wonder really. Sort of academic at this point with the NDA filing acceptance coming up within a couple of months.
Per Nasrat they were already promised priority review, which is different from Fast Track.
Q2 2015 Transcript:
"I think approval they have stated in one of their correspondence with us that they will give us expedited review."
This might help: http://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm
How many do you need?
Enough
No, perfectly relevant.
Besides, if you listened to the conference call or read the transcript of same you would know:
"We are also very involved in the sales and marketing with our partner Epic for the marketing and distribution of ELI-200. Epic has consultants working very hard with them on detailing the product across the country as a specific physicians and to all pharmacies and they are involving us with every step."
EPIC operates a 110,000 square foot facility with approximately 200 employees. Our facility is a fully functional FDA approved manufacturing facility. We utilize state of the art machinery, technology, and techniques to bring our customers high quality products on time every time. We have the ability to manufacture a diverse portfolio of products including CII - CV controlled products.
http://www.epic-pharma.com/
She did indeed. She mentioned that the team was discussing the article just before the conference call.
I just sent that to Dianne. Quite timely thanks!
Nope, old filing
Etrade shows a .4295 close w/ .424 after hours.
Nice close if I ever saw one.
We need some kitty litter I guess!
This must be the longest and most drawn out P&D in history then.
Seriously, this was .07 just a couple of years ago. Now its .40 even with all of the dilution. If this is a P&D give me more I guess.